MAUDE Adverse Event Report: LEONHARD LANG GMBH MEGADYNE; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	RSW271A30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Rash (2033); Skin Irritation (2076)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As neither a lot number nor samples have been made available to us, no analyses could be performed so far.Pictures of the rash had been provided.It is assumed the picture is showing a part of the right thigh with a line of red spots like a bruise.No further information on the patient, the application site of the dispersive electrode, the skin preparation, if and how the injury had been treated and how long after the procedure the picture of the rash had been taken have been disclosed so far despite repeated requests.We will provide any information in a follow up report.
Event or Problem Description
On (b)(6) 2018 a spinal procedure was performed at (b)(6) medical center, (b)(6).A monitoring dispersive electrode (model rs271a30) and an unknown generator were used.The initial report stated "it was reported by the sales rep that post op of a spinal procedure, reported reaction to return electrode pad.Patient has rash at site of return electrode pad.(.) no intra-operative issues." it was also stated by the initial reporter "how was the rash treated? unknown." we received photos showing the patient injury.We assume the picture is showing a part of the right thigh with a line of red spots like a bruise.
Additional Manufacturer Narrative
As neither a lot number nor samples have been made available to us, no analyses could be performed so far.Pictures of the rash had been provided.It is assumed the picture is showing a part of the right thigh with a line of red spots like a bruise.No further information on the patient, the application site of the dispersive electrode, the skin preperation, if and how the injury had been treated and how long after the procedure the picture of the rash had been taken have been disclosed to us despite of repeated requests.We have been informed by the customer that "your questionainnaire and lot/batch number requests have been sent to the sales rep multiple times with no response.No additional requests for this information will be done." based on the information made available, no conclusion can be drawn as to what might have caused the patient injury.We therfore close the investigation and the report.
Event or Problem Description
On (b)(6)2018 a spinal procedure was performed at mercy regional medical center, ohio.A monitoring dispersive electrode (model rs271a30) and an unkown generator were used.A post op skin reaction (rash) to the dispersive electrode was reported to the sales rep of the distributor.There were no inra-operative issues.It is unknown, whether the rash had to be treated.We received photos showing the patient injury.We assume the picture is showing a part of the right thigh with a line of red spots like a bruise.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 8098439
• Report Number: 8020045-2018-00023
• Device Sequence Number: 19262792
• Product Code: GEI
• UDI-Device Identifier: 19005531507774
• UDI-Public: (01)19005531507774
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RSW271A30
• Device Catalogue Number: 0855C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR